GaviLyte - C TM

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: GaviLyte - C TM
Generic name: POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK
Manufacturer: Lupin Pharmaceuticals,Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: a8b15625-ca7c-4d57-9f36-3ac2a6d13665
SPL ID: 5105b61a-4ca7-4096-9cd0-cf22f46ffaf8
Version: 4
Effective date: 2025-09-10
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:26:40

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 17 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	090186	derived:openfda.application_number
application number		ANDA090186	openfda.application_number
brand name		GaviLyte - C TM	openfda.brand_name
generic name		POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK	openfda.generic_name
manufacturer name		Lupin Pharmaceuticals,Inc.	openfda.manufacturer_name
ndc	package	43386-060-19	openfda.package_ndc
ndc	product	43386-060	openfda.product_ndc
ndc11	package	43386006019	derived:openfda.package_ndc
rxcui		967023	openfda.rxcui
rxcui		966914	openfda.rxcui
spl id		5105b61a-4ca7-4096-9cd0-cf22f46ffaf8	id
spl set id		a8b15625-ca7c-4d57-9f36-3ac2a6d13665	set_id
unii		451W47IQ8X	openfda.unii
unii		660YQ98I10	openfda.unii
unii		8MDF5V39QO	openfda.unii
unii		G2M7P15E5P	openfda.unii
unii		36KCS0R750	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Flavor pack is for use only in combination with the contents of the accompanying 4 liter container. No other additional ingredients (e.g., flavorings) should be added to the solution. GaviLyte- C with flavor pack should be used with caution in patients with severe ulcerative colitis.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Nausea, abdominal fullness and bloating are the most frequent adverse reactions, occurring in up to 50% of patients. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient. Isolated cases of urticaria, rhinorrhea, dermatitis, and rarely anaphylaxis, angioedema, tongue edema, and face edema have been reported which may represent allergic reactions.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.